okt 18, 2018: 10:45 a.m. - 11:40 a.m.
Within the past year, the FDA has launched a provider pre-certification program as a pilot to manage the expansion of %u201Cdigiceuticals%u201D or digital therapeutics that produce clinical benefits for patients via interaction with a software application or mobile app. This innovative regulatory approach seeks to provide discipline around clinical utility with the iterative improvements enabled by software versus standard manufactured medicines. Given the near-instant worldwide distribution platforms of mobile apps, the technology enables fundamental changes in managing interactions with patients to understand and treat disease, with clear collaboration benefits between biopharma and digital therapy providers. This session will feature companies trying to expand this frontier, the investors distinguishing among the competing technologies, the therapeutic partners who might benefit from such apps, and experts on the most likely pathways innovations will take to reach patients.